By Sarah Sloat

Swiss pharma company Roche said Friday it has received a positive opinion from the European Union that would extend use of its Evrysdi treatment for babies diagnosed with spinal muscular atrophy.

The positive recommendation from the EU Committee for Medicinal Products for Human Use, or CHMP, is based on interim data from an ongoing trial that showed most babies treated with Evrysdi were able to stand and walk within timeframes typical of healthy babies by 12 months of treatment, Roche said.

Evrysdi is currently approved in the EU for treating patients two months or older.

Specifically the recommendation to extend marketing authorization includes treatment for infants with genetically confirmed diagnosis of different types of spinal muscular atrophy from birth to below two months.

Write to Sarah Sloat at sarah.sloat@wsj.com

(END) Dow Jones Newswires

July 21, 2023 10:10 ET (14:10 GMT)

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